MAUDE Adverse Event Report: ARTHREX, INC. ACL TIGHTROPE RT; PIN, FIXATION, SMOOTH

Catalog Number AR-1588RT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Tissue Damage (2104); Foreign Body In Patient (2687)

Event Date 09/11/2014

Event Type  Injury  

Event Description

It was reported that when the marking on the tightrope reached the tunnel and the graft was pulled distally, it was confirmed that the button was flipped and was sitting on cortex.Then the white suture was toggled equally to bring the graft into the tunnel and when the marking on the graft went into the tunnel, the graft was pulled distally to ensure there was no movement.However, the graft came out by about 10mm when pulled distally.It was repeated another time and the same thing happened.Used instant imaging to ensure the button was on cortex but the tightrope did not have proper locking mechanism causing the graft to move out of tunnel distally.Surgeon had to make an incision on lateral side to cut-off the acl tightrope rt then un-tagged the suture on the graft and use a new one.Implant was removed from patient and surgery completed by using a new acl tightrope rt.

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested for evaluation but was not returned, therefore, the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This type of event is most likely caused by applying excessive force on the shortening strands, nicking the suture with another instrument, fraying from sharp edges of the bone tunnel.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Per customer, device not being returned.

• Brand Name: ACL TIGHTROPE RT
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4168183
• MDR Text Key: 15359541
• Report Number: 1220246-2014-00188
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: AR-1588RT
• Device Lot Number: 1189762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other